We work with partners and stakeholders in a number of ways to make improvements to different areas of the research process. These projects and collaborations complement other projects undertaken solely by the HRA.
Our Collaboration & Development Forum brings together a range of organisations that have a role in improving the environment for research, and meets quarterly. The minutes from the latest meeting of the Forum are available here, and the most recent update from its members here. To keep up to date with our projects, please subscribe to our bimonthly newsletter, HRA Latest.
These are our current work areas:
- Technical Assurances
- Complex Applications
- Working with funders
- Site/researcher competency
We have identified issues with some studies arising from variable oversight by some non-commercial sponsors, particularly for studies other than clinical trials. Led by non-commercial sponsors, we are supporting the development of a toolkit for sponsors, developing training for sponsor staff and improving escalation routes when issues arise. The Collaboration and Development Forum has established a reference group for non-commercial sponsors (link to ToR) which met for the first time in September 2014.
In February 2013 the HRA ran a stakeholder event which included a series of workshops to collate feedback on a range of collaborative workstreams, including Sponsorship Standards. As part of the output from this a consultation on sponsors responsibilities was held in 2014 as a result we have released our expectations of sponsors.
The roles and responsibilities of sponsors, including detailed information on responsibilities specifically in relation to HRA Approval, can be found here.
We have become aware that the quality and content of protocols received by the HRA and other reviewers is highly variable. Strong feedback highlighted considerable variability of content and sometimes poor quality of protocols is causing delays to reviews. In response to this we have facilitated work to develop guidance to assist organisations and individuals to improve the consistency and quality of their protocols.
Working groups of relevant experts from a wide range of organisations were convened in order to share best practice, supply content and comment on drafts of the template and guidance. These organisations were identified via existing Collaboration & Development networks and calls for volunteers. The output of these groups led to two consultations in 2015 one for CTIMPs and one for Qualitative Research which resulted in the development of protocol guidance for these research types which will be released as part of our Learning Resources later in 2016.
These learning resources are designed to:
- Provide guidance and walk people through the process of preparing a protocol for HRA Approval and other reviews.
- Support educational providers who train novice researchers.
- Improve the consistency and quality of protocol especially in qualitative research where we are aware of a large viability in quality.
- Contain of the point on the SPIRIT checklist giving assurance that protocols are in line with SPIRIT.
We continue to work with the EQUATOR Network on producing protocol guidance for other study types to align with current and future initiatives to improve the quality, reliability and value of medical research.
3. Technical Assurances
The HRA has been collaborating with Cancer Research UK (CRUK) and the Experimental Cancer Medicine Centres (ECMCs) to set up Pharmacy and Radiation Technical Assurances. The aim of HRA Technical Assurances is to reduce set-up delays caused by pharmacy and radiation reviews. Pharmacy and radiation experts have been involved directly in the development of the review processes, which were based upon those used by University College London Partners and North Thames CRN and modified accordingly. Both Pharmacy Assurance and Radiation Assurance have been rigorously tested and amended based on feedback and experience. They will be rolled out to all relevant studies and incorporated into the Assessment aspect of HRA Approval in a phased approach.
The aim of Pharmacy Assurance is to produce a consistent standard approach to pharmacy reviews created and agreed by Pharmacists. The HRA Technical Assurances team assign an appropriate Pharmacy Reviewer to undertake a single technical review ensuring that the necessary technical information is available in the study documents. The Pharmacy Reviewer collates the technical details in the standardised single technical review form which is available to all participating sites to facilitate their local capacity and capability reviews. This reduces duplication as it enables all sites to access the single technical review form, therefore reducing the number of queries from sites during their local review process. Pharmacy Assurance is currently accepting Phase I or II oncology studies where the lead site is in the ECMC network. For more information please contact: email@example.com
The aim of Radiation Assurance is to ensure that the radiation reviews in Part B of the IRAS form are completed to an agreed standard and all research exposures and risks are explained in a clear and consistent way for study participants and Research Ethics Committees (RECs). Radiation Assurance involves a validation check by the HRA Technical Assurances team to ensure that the necessary study documents are available and that all information regarding research exposures is consistent prior to radiation review. The HRA Technical Assurances team then assign an appropriate medical physics expert(s) and clinical radiation expert(s) to complete the radiation review. As the process develops, this will include providing standard IRAS statements and standard participant information sheet statements. Radiation Assurance is currently accepting oncology studies with the lead site in the ECMC network. For more information please contact: firstname.lastname@example.org
The evaluation report of the collaborative pilots between the Health Research Authority and the Experimental Cancer Medicine Centres are available here for Pharmacy Assurance and here for Radiation Assurance. The HRA’s Technical Assurance Board are pleased to publish these and will look to implement the recommendations that are viable in a broader range of NHS settings in the coming months.
The Technical Assurance Board would like to express its gratitude to all stakeholders who supported the pilots and in particular the professionals who sat on the Guardians Groups who developed the concepts, systems and supporting documentation that we can use to take the project forward.
More details of how the projects will move forward will be communicated shortly.
4. Complex Applications
Large multicentre studies and projects in hard to recruit populations e.g. rare diseases are sometimes complex to set up and recruit to in the NHS. Complexity can be due to the regulation of activity and/or the logistics of setting-up projects across primary, secondary and social care. HRA Approval has streamlined the set-up of studies across the NHS. For infrastructure projects that do not require HRA Approval (Bioresourses, databases) work is being undertaken on streamlining necessary approvals and governance arrangements to allow easy set-up and flow of material across the NHS. We are developing proposals to address specific issues faced by those working in particular research areas: rare diseases, bioresources, and regenerative medicine.
Establishing what parts of programmes or large projects are research or not will influence which regulatory and governance pathways to follow to allow smooth setup in the NHS. The HRA are working with a number of stakeholders (both commercial and non-commercial) to build confidence in what activities constitute research quick and consistent setup of programmes across the NHS. Advice on projects can be sought via the HRA Queries line.
5. Working with funders
We are working with research funders to identify how to improve the quality of research summaries. These provide information for reviewers, researchers, potential participants and the public about research projects. We want to standardise the requirements to avoid duplication in providing different summaries for different purposes. The HRA publishes the summaries submitted as part of the application for ethical review. During 2016 we will be looking beyond the approvals process to consider how to streamline progress reporting requirements and cost attribution across the whole research pathway.
We have recently worked in conjunction with NIHR funders and DH to bring about changes to the standard DH contract for research, meaning studies can be set up more promptly in more cases, and patient benefit achieved more quickly. More information can be found here.
6. Site/researcher competency
We issued a joint statement with MHRA in July 2012 on Good Clinical Practice training. We continue to encourage providers to ensure training is appropriate to different types of research and to the research activities and roles that individuals will undertake. We feel there is still a need for more training to be tailored specifically to meet the needs of those conducting research in the NHS other than clinical trials. There have been demands from some companies for better ways to assess whether researchers and sites are competent to conduct a particular study. We have been linking with collaborations in the UK and internationally to assess the potential of voluntary accreditation for sites and for researchers, and whether this would improve the quality of research and improve the set-up and delivery of projects.
Throughout 2016 and beyond we will be looking at ways in which we, researchers, funders and other regulators can build on more proportionate approaches to setting up and undertaking research in the UK. We anticipate that this will inform the discussions of HRA’s Board with regard to our strategic direction, as well as the decision makers within our stakeholders.
In addition to identifying opportunities, we are working with the community to understand what proportionality in research means to different stakeholders by using existing opportunities for discussions as well as ad hoc conversations.
In 2014 we had a team of Application Managers to support specific aspects of the research review process. They provided advice to researchers and sponsors of complex or ‘at-risk’ studies in navigating the approvals process. Learning for these situations, the resolutions for individual cases informed HRA policy and operational guidance relating to HRA Approval and their function has been written into HRA Assessors job descriptions.
In 2014, a harmonised UK-wide process for handling amendments for NHS R&D was introduced. This new system introduces a system of categorisation and presumed implementation. The HRA is responsible for managing this process for amendments for all studies, where the lead site is in England. As of 31st March 2016 this process forms part of HRA Approval. Details of the process and related guidance can be found here.